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FDA 510(k)

JFord Speculum Sleeve™

K-Number: K252208 · 2026-03-06

ApplicantFord Medtech, LLC
Decision Date2026-03-06
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

JFord Speculum Sleeve™ is the device name listed in this FDA 510(k) record. The listed applicant is Ford Medtech, LLC. It received FDA 510(k) clearance on 2026-03-06 under 510(k) number K252208. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JFord Speculum Sleeve™?

JFord Speculum Sleeve™ is a medical device that received FDA 510(k) clearance on 2026-03-06. The listed applicant is Ford Medtech, LLC. The 510(k) number is K252208.

When did JFord Speculum Sleeve™ receive FDA 510(k) clearance?

JFord Speculum Sleeve™ received FDA 510(k) clearance on 2026-03-06, under 510(k) number K252208.

Who is the listed applicant for JFord Speculum Sleeve™?

The FDA 510(k) record lists Ford Medtech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JFord Speculum Sleeve™?

The FDA product code for JFord Speculum Sleeve™ is HIB.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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